A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD) Closure

Not Applicable

• Conditions: Ventricular Septal Defect

• Registration Number: NCT03941691
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

The purpose of this clinical trial is to verify the safety and effectiveness of the Fully Absorbable VSD Occlusion System and VSD Occlusion System produced by Shanghai shape memory alloy materials co., LTD. Clinical trials are designed as prospective, multicenter, randomized controlled, noninferiority clinical trials. Prospective randomized multicenter trial involving about 108 subjects will be enrolled in 4 centers. Patients will be randomized to two groups in equal proportion (54 in each). The success rate of occlusion at 6 months after operation is the main evaluation index in this clinical trial.

Detailed Description

1. This is a prospective, multicenter, randomized and noninferiority clinical trial, which is designed to compare the effectiveness and safety with the fully absorbable ventricular septal defect (VSD) occlusion system and VSD occlusion system produced by Shanghai shape memory alloy materials co., LTD.

2. This trial will recruit about 108 subjects from 4 centers. Patients will be randomized to two groups in equal proportion (54 in each). The proposal recruiting period is 12 months and the follow-up will be performed at 1 month, 3 months and 6 months after surgery.

Study Timeline

• Study Start: 2019-04-11
• Status Verified: 2019-05
• Study First Submitted: 2019-05-05
• Study First Submitted QC: 2019-05-06
• Last Update Submitted: 2019-05-06
• Study First Posted: 2019-05-08
• Last Update Posted: 2019-05-08
• Primary Completion: 2021-04-20
• Study Completion: 2021-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Subjects and/or their legal guardians will be informed of the nature of this study and agree to participate in this clinical trial in accordance with all terms of this study.Signed the informed consent approved by the ethics committee, agreed to accept the postoperative treatment program, and completed the follow-up and related examinations as required by the follow-up;
2. Aged from 1 to 60 years old, weight more than 10 kg, male or non-pregnant women;
3. VSD effective shunt ≥3mm, ≤14mm;
4. Distance between the edge of defect and the right aortic valve is more than 3mm, no aortic valve prolapse or moderate aortic regurgitation.

Exclusion Criteria

1. Irreversible pulmonary vascular disease;Severe pulmonary hypertension with bidirectional shunt;
2. Bleeding disorders or known clotting disorders (including heparin-induced thrombocytopenia),contraindications to antiplatelet therapy, or rejection of transfusions;
3. Sepsis or severe infection within 1 month prior to occlusion;
4. Patients with thrombosis at the occluder placement and venous thrombosis at the catheter insertion site;
5. Cardiac malformation dependent on ventricular septal defect (VSD);
6. Not suitable for treatment with this product.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
success rate of occlusion at 6 months after the surgery	6 months after the surgery	Successful occlusion is that when follow-up under echocardiography at 6 months after surgery, the occlusion site shows no residual shunt or only a small amount of residual shunt.

Secondary Outcome Measures

Name	Time	Method
Surgical technique success rate	Immediately after surgery	After the occluder was implanted with surgical intervention transport device (test group) or occluder and intervention transport device (control group), the occluder was released safely.
technique success rate	Immediately after surgery	After the occluder was implanted with occluder and surgical intervention transport device (test group) or occluder and intervention transport device (control group), the occluder was released safely and no occluder detachment occurred during the operation.

Trial Locations

Locations (4)

Hefei high-tech cardiovascular hospital; 🇨🇳 Hefei, Anhui, China

Structral Heart Disease Center, Fuwai Hospital; 🇨🇳 Beijing, Beijing, China

The Second XIANGYA Hospital Of Central South University; 🇨🇳 Hunan, Changsha, China

Children's Hospital Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China